Montenegro and Croatia successfully completed the EU Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)”

The conference held in Podgorica, on 19 July 2022, marked the successful completion of the Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)”. The project, financed by the European Union and implemented by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), strengthened CInMED’s institutional capacities and visibility, enhanced pharmacovigilance and medical devices surveillance systems, and improved authorisation and inspection systems for medicines and clinical trials in Montenegro.

Through this project, the Republic of Croatia, as a Member State of the European Union (EU), provided technical support to CInMED in the process of harmonising operations and legislation with international standards and the Union acquis in the field of medicines and medical devices, not only as a part of the European integration process, but also to improve the health care system and patients’ protection in Montenegro.

The conference was opened by Asst. Prof., MD Snežana Mugoša, Beneficiary Country Project Leader and Managing Director of CInMED, thanking all the participants who contributed to the successful implementation of the project and highlighting the excellent cooperation with the partner institution, the Agency for Medicinal Products and Medical Devices of Croatia. “The project is essentially a continuation of our long-standing successful cooperation, during which HALMED became our partner and support on the way to the European Union, as well as a role model that we look up to when it comes to applying the highest EU and international standards in our work and building Institute’s potentials and credibility,” said Mugoša.

Lina Čačić, Resident Twinning Advisor on this project and HALMED employee, presented the results of the project and highlighted the most important activities. CInMED’s strategic, action and communication plans were developed, as well as the training programme for its employees. Rulebooks and guidelines in the field of medicines and medical devices, standard operating procedures and manuals for conducting inspections were prepared, as well as educational materials intended for promoting CInMED’s contribution to public health. CInMED employees were provided with the knowledge and practical experience of Croatian colleagues in the form of lectures, workshops and conduction of inspections. A meeting with the representatives of associations of healthcare professionals and patients in Montenegro, persons in charge of communication in healthcare, as well as media representatives was held, with the aim of promoting the significance of continuous monitoring of medicines safety in Montenegro. Two study visits of Montenegrin experts to the Republic of Croatia were also organized. They visited HALMED and participated as observers in the good distribution practice inspection of a wholesaler of medicines.

The Program Manager of this project at the EU Delegation, Dobromir Hristov, said that he believes that the successful work done under this project has far more reaching effects in reality: “Ensuring the high standards of medical products and medical devices are key piece in the overall puzzle, protecting the Montenegrin and EU citizens against harmful products and practices. Thus, I hope that building on the achievements of the project, the Montenegrin authorities will be able to preserve the high level of standardisation and accreditation necessary to be up to the latest in the EU on the path to accession.”

Director of HALMED and Member State Project Leader, Prof. Siniša Tomić, stated that impressive results were achieved through this project, but that the EU regulatory rules are constantly changing and improving, therefore CInMED and other Montenegrin institutions that monitor medicines and medical devices in Montenegro face more challenges in order to ensure their market has a suitable regulatory framework harmonized with EU legislation. “Through the exchange of knowledge, our experts carried out an intensive adaptation of comprehensive rules and guidelines to EU standards. I can conclude that the Union acquis has been continuously implemented during this cooperation and will continue to be applied in the development of CInMED’s institutional and regulatory capacities,” said Prof. Tomić.

EU Twinning projects are a very important mechanism for transferring the knowledge of European Union Member states to candidate countries in the specific areas important for the EU accession process. “This is the sixth of a total of seven Twinning projects in Montenegro that have so far been implemented by Croatian institutions,” said the Ambassador of the Republic of Croatia in Montenegro, H.E. Veselko Grubišić. He emphasized the commitment of the Republic of Croatia to helping Montenegro in the process of integration into the EU family and encouraged Montenegrin institutions to get more involved in EU projects and maximise the advantages they provide.

The conference was attended, among others, by representatives of the Ministry of Health of Montenegro, headed by Minister Dragoslav Šćekić, the Ministry of Economic Development and Tourism of Montenegro, the Ministry of European Affairs of Montenegro, the Directorate for Finance and Contracting of the EU Assistance Funds (CFCU) within the Ministry of Finance, Ministry of Foreign and European Affairs of the Republic of Croatia, Central Finance and Contracting Agency of the Republic of Croatia, and representatives of CInMED and HALMED.

The project was financed by the European Union in the amount of 340,000 euros and co-financed by Montenegro in the amount of 60,000 euros, for the duration of 18 months, from January 2021 to July 2022.

Three leaflets designed within EU Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” for promoting CInMED contribution to public health

As the EU Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” actively and productively heads toward its conclusion (end of implementation period being 28 July 2022), most of the indicators set to measure the Project progress have been successfully achieved.

Among them, recently published leaflets designed for promoting CInMED contribution to public health are of particular and direct interest for Montenegrin public, since they bring forward three very important topics and CInMED’s role in it:

1. Falsified Medicines: besides giving facts about falsified medicines and how everybody can contribute in combating this global health issue, the leaflet intends to raise awareness of the risks associated with buying medicines from unregulated websites The brochure is available here

2. Reporting side effects – a patient guide: this leaflet gives “all you need to know” information on suspected adverse drug reactions and how to report them in a concise and patient-friendly way The brochure is available here

3. Over-the-counter (OTC) medicines: this leaflet aims to ensure the correct use of OTC medicines, since they can be acquired without doctor’s prescription, and to raise awareness of the importance of cautious reading of the Patient Leaflet The brochure is available here

EU Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” – Overview 2021

On 7 December 2021, the 4th Project Steering Committee Meeting of the EU Twinning Project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” took place in a hybrid live/on-line format at CInMED’s premises in Podgorica, with a number of PSC members participating remotely. The major result of the meeting was the adoption of the 4th Rolling Work Plan, which covers the project activities till the end of the implementation period, i.e. 28 July 2022.

Opportunity was taken to reflect favourably on the challenging, both in health and political area, year of 2021, with undivided opinion that Twinning team has shown great flexibility and resourcefulness and overcame obstacles in the most optimal and effective way.

Since the beginning of the implementation of the Project on 29 January 2021, majority (11) of the missions were executed remotely due to COVID-19 pandemic, but four (4) were organised in Montenegro and two (2) in the hybrid live (Montenegro)/on-line format. Also, one study visit for the BC experts to the Member state was successfully carried out.

Activities in all 3 components have started, with Component 2 (Post-marketing Pharmacovigilance System and Medical Devices Surveillance System in Montenegro enhanced) being the most completed one and achieved so far through knowledge and experience exchange seminars and workshops, complemented with an awareness raising meeting, which all helped to optimise processes to ensure safety of authorized medicines and medical devices.

At the very beginning of the project implementation, comprehensive analysis of CInMED’s procedures and systems in place was performed and CInMED’s needs defined, result of which was development of CInMED’s Strategy with Action plan and Training programme. This was followed with drafting of a Communication Action Plan, which accompanied training seminars related to effective communication with stakeholders and promoting the visibility of CInMED as a public health institution.

Furthermore, assessment report analysing harmonization of in-force secondary legislation in the field of medicines and medical devices in Montenegro with the Union acquis was composed and work on the harmonisation (revising existing and drafting new rulebooks/guidelines) started.

A lot of progress has been achieved in the area of inspections, with trainings in GMP (Good Manufacturing Practice), GVP (Good Pharmacovigilance Practice) and GDP (Good Distribution Practice) inspections successfully carried out. Trainings included real on-site inspections, of which inspection of a manufacturing site and marketing authorisation holder were performed in Montenegro and of a wholesaler in a study visit to Croatia.

Several trainings (5 in total) in assessment of documentation for medicines and medical devices have been executed and knowledge and experience already implemented in CInMED’s everyday work. Trainings included consultations and peer-review of real-life cases currently under CInMED’s assessment.

Also, training in the area of clinical trials has started, with the mission dedicated to clinical trial approvals.

Activities were not limited to CInMED (the primary beneficiary of the project), but also included other stakeholders. This was accomplished through two meetings – one on-line half-day seminar in collaboration with the Pharmaceutical Chamber of Montenegro (with more than 150 participants, mostly pharmacists), and the other awareness raising meeting at the premises of CInMED focused on the representatives of associations of healthcare professionals and patients in Montenegro, persons in charge of communication in healthcare, as well as media representatives.

Have a look at the video to see our experts at work.

IMPORTANT NOTE: The well-being and health of all project participants are of the utmost importance. All activities / meetings are risk assessed and performed in compliance with the mitigation measures advised.

This publication was produced with the financial support of the European Union. Its contents are the sole responsibility of RTA office and do not necessarily reflect the views of the European Union.

Meeting „Working Together for Safe Use of Medicines“

held in CInMED

On 4th November 2021, meeting entitled “Working Together for Safe Use of Medicines” was held at the premises of the Institute for Medicines and Medical Devices (CInMED). The meeting was organized within the EU Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)”, which is implemented in cooperation with the Croatian Agency for Medicinal Products and Medical Devices (HALMED), and is funded, i.e. co-funded by the European Union and Montenegro.

The aim of this meeting was to promote significance of continuous monitoring of medicines safety in Montenegro and to present a patient’s guide on how to report suspected adverse drug reactions, which can be downloaded here.

CInMED’s Department for Pharmacovigilance representatives, Maja Stanković and Veselinka Vukićević, along with the representatives of HALMED’s Department for Pharmacovigilance and Rational Pharmacotherapy, Nikica Mirošević Skvrce and Morana Pavičić, introduced participants with the pharmacovigilance system in Montenegro and in the Republic of Croatia.

It was pointed out that reporting of adverse drug reactions is highly important, since the analysis of collected data enables better understanding of the safety profile of a medicine, and makes prescribing and use of medicines safer and more efficient.

The meeting was attended by the representatives of associations of healthcare professionals and patients in Montenegro, persons in charge of communication in healthcare, as well as media representatives. Lectures and discussion that followed gave participants the opportunity to learn more about how to report suspected adverse drug reactions, find out what happens to the received report, and also learn how healthcare professionals and patients can contribute to the safe use of medicines and directly contribute to the protection of public health in Montenegro.

This meeting was held in the week of global campaign dedicated to reporting adverse drug reactions, #MedSafetyWeek, organized by Uppsala Monitoring Center (UMC) in collaboration with medicines regulatory agencies around the world.

The 3rd Project Steering Committee meeting of the EU funded Twinning project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” held on 28 September 2021

The third Project Steering Committee meeting (PSCM) of the EU funded Twinning Project “Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)” was held on 28 September 2021, at the premises of CInMED in Podgorica, Montenegro.
The aim of the meeting was to discuss main results achieved during the second quarter of project implementation and to present project activities included in the Rolling Work Plan No. 3.

The meeting was attended by representatives of the Montenegrin and Croatian regulatory authorities, namely Ms Željka Bešović, Beneficiary Country Project Leader and the Head of the Centre for Medicines in CInMED; Mr Siniša Tomić, Member State Project Leader and the Head of the Agency for Medicinal Products and Medical Devices of Croatia (HALMED); Ms Mira Kontić, the acting Director of CInMED; Ms Lina Čačić, Resident Twinning Advisor (RTA) and the Senior Advisor – Specialist II in HALMED; and Ms Maja Stanković, RTA Counterpart, Component Leader 2 and the Head of the Centre for Medicines postmarketing surveillance in CInMED. Furthermore, representatives from the Directorate for Finance and Contracting of the EU Assistance Funds (CFCU) of Montenegro Ms Iva Vujović; the Ministry of Economic Development of Montenegro Ms Rosanda Jocović, the Delegation of the European Union to Montenegro Mr Domagoj Denačić, the European Integration Office of Montenegro Mr Bojan Tenjović and Croatian Central Finance and Contracting Agency (CFCA) Ms Nikolina Likó, attended the meeting.

Several significant changes have taken place in the project management team due to the retirement of the previous BC Project Leader and Director of CInMED Mr Milorad Drljević in June 2021: he was replaced as a BC Project Leader with Ms Željka Bešović, previous RTA counterpart, and consequently, RTA Counterpart has changed to Ms Maja Stanković. This changes were endorsed by EUD, approved and notified by CFCU on 18 August 2021, together with the change of the project name from “Support to the Agency for Medicines and Medical Devices of Montenegro (CALIMS)” to „Support to the Institute for Medicines and Medical Devices of Montenegro (CInMED)“.

Ms Željka Bešović and Ms Maja Stanković, who were involved in the project from the beginning in their respective roles as RTA Counterpart and Component Leader 2, expressed enthusiasm for their new roles and their commitment to the realization of the mandatory results. Both highlighted the importance of cooperation and exchange of experience with Croatian partners with the support of the Twinning project.

The newly appointed Acting Director of CInMED Ms Mira Kontić, who was involved in the project from the beginning in the role of CInMED’s legislation expert, took the opportunity to introduce herself to the PSCM participants and to express her full support for the project.

In his turn, the MS Project Leader Mr Siniša Tomić, expressed his pleasure in meeting the new management of CInMED and Twinning team, and his confidence that the cooperation will continue as smoothly and successfully as before, both in terms of the project and between HALMED and CInMED.

Meeting continued with the RTA Ms Lina Čačić presenting the overview of the project progress since the last PSCM held on 15 June 2021 and the planned activities for the period 1 August 2021 – 28 March 2022. The representative of the CFCA Ms Nikolina Likó contributed to the presentation with the project budget realisation.

During second reporting period (May to July 2021), activities started in Component 2, and continued in Component 3, with focus on training activities. Since a new extension of the flexibility arrangements regarding Twinning contracts in the context of the COVID-19 crisis situation has been adopted by European Commission, remote work remained the main modus operandi. Still, remote work has not negatively impacted the project work and progress. Missions were very effective, cooperation between partners intensive and very successful and production of project outputs and deliverables according to plan, regardless of being implemented remotely or in Montenegro.

The following mandatory results were achieved during the second reporting period:

Component 2

• Delivering training seminars and knowledge-exchange workshops on Member State practices – Pharmacovigilance and Medical Devices
• Increasing administrative capacity of CINMED’s staff to perform pharmacovigilance inspections

Component 3

• Conducting training on the assessment of validity of marketing authorisation applications/ variations/renewals for medicines
• Conducting training on the assessment of bioequivalence studies
• Conducting training on clinical trials

The PSCM participants favourably assessed the progress of the project and adopted the Rolling Work Plan No. 3, revised Communication and Visibility Plan and the Interim Quarterly Report No. 2.

During the meeting, the next (4th) PSCM was scheduled for 7th December 2021.

IMPORTANT NOTE: The well-being and health of all project participants are of the utmost importance. All activities / meetings are risk assessed and performed in compliance with the mitigation measures advised.

This publication was produced with the financial support of the European Union. Its contents are the sole responsibility of RTA office and do not necessarily reflect the views of the European Union.

EU Twinning Project

MN 16 IPA HE 01 20 – First Quarter Activities Overview

During the first implementation quarter of the Twinning project “Support to the Agency for Medicines and Medical Devices of Montenegro (CALIMS)” MN 16 IPA HE 01 20, from January to April 2021, seven missions, with total of 37 working days, were executed by 8 Croatian experts.

Montenegrin and Croatian experts successfully implemented the following activities with enthusiasm and eagerness:

• Training needs analysis for CInMED’s (*) employees was conducted, based on which draft of long-term Training programme was compiled
• Draft of CInMED’s Strategy with Action plan was prepared for the development of CInMED’s capacities and better organization and management
• Assessment report was composed analysing the degree of harmonization of Montenegrin in-force secondary legislation in the field of Medicines and Medical Devices with EU acquis and list of Rulebooks/Guidelines to be prepared/revised was compiled
• Training on EU legislative requirements and guidelines regarding EU Marketing Authorisation in the area of veterinary medicines, as the fundamental part of training on assessment of documentation (validity, quality, safety and efficacy) of human and veterinary medicines, was conducted
• Training on EU GMP inspection procedures and good practices in their application and GMP on-the-spot inspection was conducted

Due to on-going COVID-19 pandemic, missions were held remotely via on-line platform, with the exception of the on-the-spot GMP inspection at the premises of Hemomont d.o.o. in Podgorica, Montenegro, where CInMED’s inspectors were joined by HALMED inspectors.

Even in these COVID-19 pandemic conditions, the degree of cooperation between partners at all levels is more than satisfactory and everyone showed a remarkable dedication and support to the project.

Ultimately, substantial progress was made in preparing documentation fundamental for further business, and all of the so far held missions contributed to increasing the overall capacities of CInMED, touching the practices and mechanisms applied in EU Member States that can be of service in achieving improvements in the pharmaceutical sector in Montenegro.

More about the project: EU Twinning project MN 16 IPA HE 01 20

(*) Institute for Medicines and Medical Devices of Montenegro (CInMED); formerly Agency for Medicines and Medical Devices of Montenegro (CALIMS)

The first Project Steering Committee meeting for the EU funded Twinning project “Support to the Agency for Medicines and Medical Devices of Montenegro (CALIMS)”

The first Project Steering Committee Meeting (PSCM) for the EU funded Twinning project “Support to the Agency for Medicines and Medical Devices of Montenegro (CALIMS)” was held via on-line platform on 16 March 2021.

Mr Milorad Drljević, BC Project Leader and the Director of the Institute for Medicines and Medical Devices of Montenegro (CInMED; formerly “Agency for Medicines and Medical Devices – CALIMS”), and Mr Siniša Tomić, MS Project Leader and the Head of the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) opened the meeting and welcomed the participants. The Resident Twinning Advisor Ms Lina Čačić presented the overview of the project progress since the start of implementation period and the planned activities for the next period.

Representatives of the Directorate for Finance and Contracting of the EU Assistance Funds (CFCU) of Montenegro Ms Iva Vujović, the Ministry of Economic Development of Montenegro Ms Rosanda Jocović and Resident Twinning Advisor Counterpart Ms Željka Bešović also attended the meeting as PSC members.

The representatives of the Delegation of the European Union to Montenegro Mr Dragan Radanović, the European Integration Office of Montenegro Mr Bojan Tenjović and Croatian Central Finance and Contracting Agency (CFCA) Ms Nikolina Likó, participated in the meeting as observers.

The PSCM participants approved and adopted the Initial Rolling Work Plan and the Communication and Visibility Plan for the first 7 months of the project (29 January 2021 – 28 August 2021), gave a positive evaluation to the start and the initial course of the project and expressed readiness for further cooperation to provide support to its activities. The quality cooperation between Montenegrin and Croatian institutions was pointed out.

Republic of Croatia provides support to Montenegro through implementation of the EU funded Twinning project in the area of Medicines and Medical Devices

On 29 January 2021, the European Union Twinning project “Support to the Agency for Medicines and Medical Devices of Montenegro (CALIMS)” was launched, with the arrival of the Resident Twinning Advisor (RTA) to Podgorica, the capital of Montenegro. The Institute for Medicines and Medical Devices of Montenegro (CInMED; formerly “Agency for Medicines and Medical Devices – CALIMS”), is the sole Beneficiary Institution of this Twinning Project.

The Member State (MS) Twinning project partner is the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), in cooperation with the Ministry of Health of the Republic of Croatia, the Faculty of Medicine of University of Rijeka and Croatian Central Financing and Contracting Agency (CFCA).

The overall objective of the project is to assist Montenegro in the process of accession to the EU by contributing to legislation alignment and enforcement in the field of free movement of goods (Chapter 1), with special focus on finalising the transposition of the Union acquis and supporting the application of the EU and international good practices (ICH, PIC/S …) in the field of pharmaceuticals and medical devices.

The specific objective of the project is to enhance and consolidate the institutional and operational capacities of the Institute for Medicines and Medical Devices of Montenegro (CInMED) to perform its statutory duties and contribute to the health care system improvement and patients’ protection, by ensuring compliance with the EU standards, guidelines and good practices relevant to Chapter 1 of the Union acquis – ‘Free Movement of Goods’ concerning registration, marketing and consumption of medicines and medical devices.

The MS Project Leader is Mr Siniša Tomić, Head of HALMED. Representative of HALMED, Ms Lina Čačić, in her role of RTA, coordinates and monitors project implementation under the overall supervision of the MS Project Leader.

On behalf of Beneficiary Country (BC), the Project Leader is Mr Milorad Drljević, Director of CInMED, while RTA Counterpart is Ms Željka Bešović, CInMED Head of the Centre for Medicines.

The team of high-level professionals from BC and MS will jointly work to ensure extensive transfer of knowledge and experience, with the aim of successful implementation of this project.

In the period 16 – 18 February 2021, partners from BC and MS sides conducted a series of online meetings on all project components, with a view to identify CInMED’s current priorities, detail activities and develop the Initial rolling work plan for the first 7 months of the project.

The project is co-financed by the EU and Montenegro with the value of EUR 400,000.00 and the implementation period is 18 months (29 January 2021 – 28 July 2022).